Healthcare Industry News: abdominal aortic aneurysm
News Release - November 9, 2006
Endologix Announces Limited Voluntary Recall of Visiflex 155 mm Delivery CathetersScheduled Procedures Continuing
IRVINE, Calif.--(HSMN NewsFeed)--Endologix, Inc. (Nasdaq:ELGX ) today announced the limited voluntary recall of 30 Visiflex(TM) bifurcated delivery catheters for its PowerlinkŪ System (models 25-16-155BL and 28-16-155BL) located at seven customer sites. Based on a single field occurrence due to the failure of a catheter component manufactured by a third party, the Company has determined that these catheters should be recalled. No other delivery catheters for the PowerlinkŪ System are affected.
This particular component is used in one specific catheter length (155 mm), which is utilized in approximately 15% of Powerlink procedures. In many instances, other catheter lengths can be used for these cases. Endologix does not expect this action to limit its ability to supply other Visiflex delivery catheters to the market.
Endologix has notified the U.S. Food and Drug Administration (FDA) Los Angeles District Office and intends to initiate and rapidly complete this voluntary recall.
"We initiated this voluntary action based on a single clinical incident involving separation of the front sheath preventing deployment of the stent graft. This required the physician to convert the patient to conventional open repair. We have pro-actively identified corrective actions at Endologix to ensure the quality of purchased catheter components, and we are working with our component vendors to resolve this issue," said Paul McCormick, Chief Executive Officer of Endologix.
"This action affects a very limited number of devices and because the defect can be identified by non-destructive testing, we anticipate that the financial impact to Endologix will not be material," McCormick added. All affected consignees have been contacted and instructed to return the specified product to Endologix.
Endologix, Inc. develops and manufactures minimally invasive treatments for vascular diseases. Endologix's Powerlink System is an endoluminal stent graft (ELG) for treating abdominal aortic aneurysms (AAA). AAA is a weakening of the wall of the aorta, the largest artery in the body, resulting in a balloon-like enlargement. Once AAA develops, it continues to enlarge and, if left untreated, becomes increasingly susceptible to rupture. The overall patient mortality rate for ruptured AAA is approximately 75%, making it the thirteenth leading cause of death in the U.S. Additional information can be found on Endologix's Web site at www.endologix.com.
This press release contains forward-looking statements with respect to the scope and impact of the voluntary recall, the subsequent acceptance of the Powerlink System by physicians, and product liability claims, the accuracy of which are necessarily subject to risks and uncertainties, all of which are difficult or impossible to predict accurately and many of which are beyond the control of Endologix, all as more fully described in the risk factors and other matters set forth in Endologix Annual Report on Form 10-K for the year ended December 31, 2005, and Endologix' other filings with the Securities and Exchange Commission. Endologix undertakes no obligation to revise the forward-looking statements contained herein to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
Issuer of this News Release is solely responsible for its
Please address inquiries directly to the issuing company.